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Diss Factsheets
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EC number: 208-634-1 | CAS number: 536-45-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 10 Aug - 03 Nov 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human Repeat Insult Patch Test (RIPT)
- Principles of method if other than guideline:
- - Principle of test:
The sensitization potential of the test item (3% in glycerine) was tested on 56 subjects (19 males and 37 females). Testing was done in accordance with a modified Draize assay employing an 8 mm Finn Chamber (an occlusive patch). For the induction phase the products were applied to the scapular back Monday, Wednesday, and Friday of each week for 3 consecutive weeks, with a final patch on Monday of the 4th week, for a total of ten applications. Scoring of the skin sites was made at the end of each 48 hour patch period (72 hours on Weekends). The final reading was made on Wednesday of the fourth week.
Following a 12-day rest period each subject received a single 48-hour occlusive challenge patch of the product on a naive skin site on the scapular back. Scoring of the challenge sites was made after removal of the patch and again two days later.
- Parameters analysed / observed: erythema, edema, vesicles, bullae, toxicity/adverse effects - GLP compliance:
- no
- Remarks:
- not applicable
Test material
- Reference substance name:
- p-anisic acid
- EC Number:
- 202-818-5
- EC Name:
- p-anisic acid
- Cas Number:
- 100-09-4
- Molecular formula:
- C8H8O3
- IUPAC Name:
- 4-methoxybenzoic acid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 56
- Sex: 19 males and 37 females
- Age: not specified
- Race: not specified
- Demographic information: not specified - Clinical history:
- not applicable
- Controls:
- not applicable
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: 8 mm Finn chamber
- Vehicle / solvent: unchanged (no vehicle)
- Volume applied: approximately 0.025 mL (0.017 - 0.025 mL)
- Testing/scoring schedule: The test material was applied 3 times a week (Monday, Wednesday, Friday) for a total af 10 applications. At the end of each 48 h period (72 h an the weekend), the patches were removed and the sites were read. After reading the tenth induction patch, the subjects were rested for 12 days, during which time no patches were applied. At the end of the rest period, occlusive challenge patches were applied to new sites on the scapular back. The challenge patches remained in place for 48 h, after which the subjects returned for a reading of the test sites. Subjects then returned 2 days later for a 96 h reading.
- Removal of test substance: after removal of the test sites, the sites were rinsed with distilled water
EXAMINATIONS
- Grading/Scoring system: 0 = No reaction (negative reading), 1 = Erythema throughout the entire patch area, 2 = Erythema and edema, 3 = Erythema, edema and vesicles, 4 = Erythema, edema and bullae
- Statistical analysis: not specified
Results and discussion
- Results of examinations:
- SYMPTOMS
- No product-related systemic adverse reactions were noted during the study. However, one subject suffered a transient ischernic attack just prior to the challenge week and one subject was hospitalized for a kidney infection during challenge week. Both subjects have completely recovered.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 56
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 3 (11 reactions noted)
Applicant's summary and conclusion
- Conclusions:
- The test item was tested for its skin sensitizing potential in an RIPT in volunteers at a concentration of 3% in glycerine. Based on the results of this study the test substance is not considered a skin sensitizer in humans.
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